ACRP-MDP cheat sheet

Medical device: any instrument, apparatus, implement, machine, appliance, implant, reagent, software, or material intended by the manufacturer for a medical purpose (diagnosis, prevention, monitoring, treatment, alleviation, or contraception).

IVD (in vitro diagnostic): a device intended to examine specimens derived from the human body to provide information on physiological or pathological states, congenital abnormalities, safety, or compatibility.

Device classification (risk-based): Class I (low), II (moderate), III (high) in the US; in the EU risk classes are I, IIa, IIb, and III under the MDR; class drives regulatory pathway and controls.

Significant risk vs. non-significant risk: SR devices require an IDE (Investigational Device Exemption) and full IRB review; NSR devices are governed by abbreviated requirements, including IRB approval and informed consent.

510(k) premarket notification: demonstrates substantial equivalence to a legally marketed predicate device; PMA (Premarket Approval): required for Class III devices and requires valid scientific evidence of safety and effectiveness.

Primary endpoint: the outcome used to answer the primary hypothesis; secondary endpoints support or add to it; a surrogate endpoint is a laboratory or biomarker measure used as a substitute for a clinical outcome.

Clinical investigation plan (CIP): the document describing rationale, objectives, design, methods, statistical analysis, monitoring, and records for a device trial; equivalent to a protocol.

Vulnerable subjects: individuals whose willingness to volunteer may be unduly influenced (e.g., prisoners, employees, students, economically disadvantaged, cognitively impaired); require additional safeguards.

Blinding: single-blind = subject unaware; double-blind = subject and investigator unaware; open-label = no masking; device trials are often difficult to blind due to device appearance or procedural nature.

ISO 14155 governs good clinical practice for clinical investigations of medical devices in humans; the 2026 revision aligns terminology and expectations with ICH E6 (R2/R3) principles.

Informed consent must be obtained before any investigation-specific procedure; the consent form must state the investigation is research, describe risks/benefits, alternatives, and the right to withdraw without penalty.

Sponsor responsibilities: quality management system, CIP development, investigator selection, monitoring, safety reporting, device accountability, and audit; the sponsor may transfer duties in writing.

Investigator responsibilities: conduct per CIP, obtain consent, record source data, report adverse events, ensure device accountability, and maintain essential records for the required retention period.

Ethics committee (EC/IRB) approval must be obtained before the investigation begins and for substantive amendments; the EC must include members with appropriate expertise and at least one independent member.

Safety reporting: serious adverse events (SAEs) and device deficiencies are reported to the sponsor within timelines set by the CIP; the sponsor reports serious adverse device effects (SADEs) to authorities and ECs per regulation.

Device accountability: the sponsor must maintain records of device shipment, receipt, use, return, and disposal; investigators must document use and return of all devices.

Monitoring: risk-based monitoring is acceptable; the monitor verifies that reported data match source documents, that the CIP is followed, and that the device is used per the approved instructions.

Essential documents: CIP, EC approvals, consent forms, investigator CVs, device accountability records, CRFs, SAE reports, and final report must be retained per the applicable retention period after investigation completion.